Wayne County Chapter of NYARC
Form 483 issued September 16, 2020 · Newark, New York
- Inspection
- Sep 16, 2020
- Investigator
- William Leonard
- Observations
- 6
- Pages
- 3
- FEI number
- 3004290217
In short: On September 16, 2020, FDA issued a Form 483 with 6 observations to Wayne County Chapter of NYARC in Newark, New York (FEI 3004290217) after an inspection that ran Sep 16, 2020. The investigator was William Leonard. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Employees are not given training in current good manufacturing practices and written procedures required by current…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmWayne County Chapter of NYARC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wayne County Chapter of NYARC?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Wayne County Chapter of NYARC?
William Leonard is named on this Form 483, for the inspection of Sep 16, 2020. Each investigator has a profile showing what they cite most.
When was Wayne County Chapter of NYARC inspected by FDA?
The inspection ran Sep 16, 2020, and the Form 483 is dated September 16, 2020.
How do I get the full Form 483 for Wayne County Chapter of NYARC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.